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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro cytogenicity / chromosome aberration study in mammalian cells
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Peer reviewed authority database (Peer review was conducted by a Japanese toxicological expert group at March 5, 2001. However, detailed information were not available). Furthermore test results were taken for the OECD SIDS Intital assessment report for C.I. Pigment Yellow 53.

Data source

Referenceopen allclose all

Reference Type:
other: Peer-reviewed database
Title:
Unnamed
Year:
2002
Reference Type:
other: OECD Substance initial assessment report (SIAR)
Title:
Unnamed
Year:
2002

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
Deviations:
not specified
GLP compliance:
yes
Type of assay:
in vitro mammalian chromosome aberration test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Purity 100 %
- Lot/Batch No.: 4879

Method

Species / strain
Species / strain:
other: Chinese hamster lung (CHL/IU) cells
Additional strain characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
rat liver induced with phenobarbital and 5,6-benzoflavone
Test concentrations with justification for top dose:
short-term treatment (-S9 mix): 4.88, 9.77, 19.5, 39.1, 78.1 µg/mL;
short-term treatment (+S9 mix): 19.5, 39.1, 78.1, 156, 313, 625, 1250 µg/mL;
continuous treatment (-S9 mix): 4.88, 9.77, 19.5, 39.1, 78.1 µg/mL
Vehicle:
- Vehicle(s)/solvent(s) used: water
Controls
Negative controls:
not specified
Solvent controls:
not specified
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: -S9: Mitomycin C; +S9: Cyclophosphamide
Details on test system and conditions:
NUMBER OF CELLS EVALUATED: 200

Results and discussion

Test results
Species / strain:
other: Chinese hamster lung (CHL/IU) cells
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
yes
Remarks:
Cytotoxicity was observed at more than 39.1, 78.1, and 19.5 µg/ml in -S9mix, +S9mix and continuous treatments, respectively
Vehicle controls valid:
not specified
Negative controls valid:
not specified
Positive controls valid:
not specified
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative